Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
1849–1872 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 30, 2020
Smart Alarm Interface
K193421 · MSX
Boxview, LLC
Cardiovascular · 326d
Cleared Oct 30, 2020
eCordum Cardiac Monitor (eCordum CM)
K193296 · DXH
Ecordum, Inc.
Cardiovascular · 338d
Cleared Oct 26, 2020
coraForce and coraFlex Support Catheters
K201811 · DQY
Reflow Medical, Inc.
Cardiovascular · 117d
Cleared Oct 23, 2020
Drakon and Sequre Microcatheters
K202797 · DQO
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 30d
Cleared Oct 23, 2020
OXY-1 System
K200109 · DTZ
Abiomed, Inc.
Cardiovascular · 280d
Cleared Oct 16, 2020
Quantum Ventilation Module
K202733 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 28d
Cleared Oct 16, 2020
Selectra 3D Outer Guiding Catheters
K193474 · DQY
Biotronik, Inc.
Cardiovascular · 305d
Cleared Oct 14, 2020
Merit Hydrophilic Guide Wire
K201595 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 124d
Cleared Oct 09, 2020
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
K201377 · LIT
Cordis Corporation
Cardiovascular · 136d
Cleared Oct 09, 2020
Multi-LinkTM X2 ECG Adapter and Leadwires
K200510 · DSA
Vyaire Medical, Inc.
Cardiovascular · 221d
Cleared Oct 09, 2020
V20, V20a, AVSM3 SNF
K200434 · DXN
Mediana Co., Ltd.
Cardiovascular · 228d
Cleared Oct 09, 2020
Stethee Pro 1, Stethee Pro Software System
K193631 · DQD
M3Dicine Pty , Ltd.
Cardiovascular · 287d
Cleared Oct 08, 2020
ECG App
K201525 · QDA
Apple, Inc.
Cardiovascular · 122d
Cleared Oct 06, 2020
iSleeve Introducer Set
K202584 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 06, 2020
TruForm Sievers Annuloplasty Ring
K202253 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 57d
Cleared Oct 02, 2020
Quantum Workstation 12 Elite
K202557 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 29d
Cleared Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · QEW
Boston Scientific Corporation
Cardiovascular · 57d
Cleared Oct 01, 2020
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
K201446 · DQK
Edwards Lifesiences, LLC
Cardiovascular · 122d
Cleared Oct 01, 2020
ECG Cables and Leadwires
K201359 · DSA
Xinkang Medical Instrument Co. , Ltd.
Cardiovascular · 133d
Cleared Sep 29, 2020
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50...
K191738 · DPS
Philips Medical Systems
Cardiovascular · 459d
Cleared Sep 28, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K202543 · DQX
Volcano Corporation
Cardiovascular · 26d
Cleared Sep 23, 2020
Halo AF Detection System
K201208 · DXH
Livmor
Cardiovascular · 141d
Cleared Sep 21, 2020
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
K201467 · DXN
Bioland Technology, Ltd.
Cardiovascular · 111d
Cleared Sep 21, 2020
Pounce Thrombus Retrieval System
K192814 · QEW
Surmodics,Inc.
Cardiovascular · 356d